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Efficacy of Topical Cyclosporin for Ocular Rosacea

NCT ID: NCT00348335

Last Updated: 2011-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-09-30

Brief Summary

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The purpose of this study is to determine whether Restasis (topical cyclosporin) is effective in the treatment of ocular rosacea

Detailed Description

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The study is designed to compare the efficacy of topical cyclosporin (Restasis) with that of Refresh Endura for the treatment of the signs and symptoms of ocular rosacea in patients presently controlled on topical corticosteroids

Conditions

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Rosacea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1: Restasis

Group Type ACTIVE_COMPARATOR

Cyclosporine 0.05%

Intervention Type DRUG

2: Refresh Endura

Group Type ACTIVE_COMPARATOR

Ocular lubricant

Intervention Type DRUG

Interventions

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Cyclosporine 0.05%

Intervention Type DRUG

Ocular lubricant

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient at least 18 years old, but younger than 65
* Diagnosis of acne rosacea
* Active ocular rosacea based on lid findings of meibomian gland dysfunction with lid telangiectasia and hyperemia of at least 2+
* Schirmers test of greater than 5mm in at least 1 eye
* If patient currently using lid hygiene must maintain regimen during study
* Stop oral antibiotics at least 4 weeks prior

Exclusion Criteria

* Use of topical cyclosporin within last 90 days
* Visual acuity of 20/100 or better in both eyes
* Pregnant or lactating females
* Active ocular infection
* Scarring of central cornea
* Eyelid defects,abnormal lid positioning or lagophthalmos
* Flax seed or Fish oil supplements within last 30 days
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Allergan

INDUSTRY

Sponsor Role collaborator

Ophthalmic Consultants of Long Island

OTHER

Sponsor Role lead

Responsible Party

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OCLI

Principal Investigators

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John R Wittpenn, MD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmic Consultants of Long Island

Locations

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2500 Rte 347 Bldg 24

Stony Brook, New York, United States

Site Status

Countries

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United States

Other Identifiers

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32,133

Identifier Type: -

Identifier Source: org_study_id